Comparison · NCT04124705-sae
Armour® Thyroid vs Levothyroxine: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Armour® Thyroid vs Levothyroxine: serious adverse events. Trial comparisons, record NCT04124705-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04124705-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0284 | 0.0111 | 0.0707 | wilson | |
| Risk in group 2 | 0.049 | 0.0239 | 0.0976 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0206 | -0.0722 | 0.0286 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.58 | 0.173 | 1.94 | log | |
| Odds ratio, group 1 over group 2 | 0.567 | 0.162 | 1.98 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Armour® Thyroid than on Levothyroxine | 48.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Armour® Thyroid | Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of TSH, in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period). | 4 | 141 | EG000 |
| Group 2 | Levothyroxine | Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period). | 7 | 143 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
- NCT number
- NCT04124705
- Phases
- PHASE2
- Conditions
- Hypothyroidism, Thyroid Disease, Euthyroid, Thyroid Gland, Thyroid Hormones
- Interventions
- Armour® Thyroid, Levothyroxine
- Lead sponsor
- Allergan
- Results first posted
- 2024-06-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04124705?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT04124705-sae